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Pharmaceuticals

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Whether it be accelerated aging, seal strength, cold chain, or standard package testing, Keystone Package Testing can meet the transit testing needs of pharmaceutical companies. We are an ISO-17025 accredited test lab and our team creates an accurate test plan and provides reports in a timely manner. Having a large lab, we can often provide immediate scheduling. We also can test individual boxes up to oversized pallets. Ready to get started? Request a quote to see why so many pharma companies partner with Keystone Package Testing. Contact us to receive more information on pharmaceutical package testing.

Summary of Pharmaceutical Package Testing

Pharmaceutical packaging ranges widely depending on the chemical makeup of the drug or vaccine. Packages should be able to withstand the stresses of manufacturing, storage, transportation, and distribution.

As an internationally accredited laboratory with extensive experience in package testing, Keystone is the best pharmaceutical packaging test laboratory to partner with.

Why is Pharmaceutical Package Testing and Compliance Important?

Manufacturing, distribution, and transportation are the areas that pharmaceuticals experience the most stress. The distribution channel can be tough on the packaging. From drops, shakes, and temperature variations, it is imperative that a package is able to maintain its integrity throughout the process.

Pre-conditioning and conditioning tests are common types of testing for changes in temperature and humidity. Exposing the package to these types of environmental stresses allows the lab to check the effects on the integrity of the package. Should the package warp or deteriorate due to the simulated stresses, it should still maintain sterility and the ability to protect the product inside.

Additionally, dealing with pharmaceutical packages, sterility is an important component of distributing pharmaceutical products. The seal on the packaging must be composed in such a way that it will not break and result in a breach of sterility.

Regardless of the specific type of package, it is important for the drug or vaccine to reach its destination ready to be administered to those who need it.

Common Pharmaceutical Package Testing Types

Accelerated Aging

The accelerated aging packaging test is the process of introducing temperature and humidity to expedite the deterioration of materials. Oftentimes, a sterile barrier system has an expiration date because sterility can no longer be guaranteed. Over time, the adhesive materials or cohesive bonds that maintain sterility begin to degrade and the package is compromised.

For more information on Accelerated Aging, please visit the links:

Gross Leakage / Dye Penetration

ASTM F2096, known as the Bubble Test, measures the material integrity of the package. This test consists of submerging the package under water and increasing the internal pressure of the package. Dye penetration package testing is useful for measuring the effectiveness of package seals for a complete seal that will keep the drug sterile under stressful conditions.

Seal Strength

ASTM F88 only tests a portion of the seal. This test measures the force required to separate a test strip of material containing the seal. ASTM F88 also identifies the mode of specimen failure.

ASTM F2824 tests the force required to separate the entire lid from a container. This test differs from ASTM F88. ASTM F2824 uses an angle of 45 degrees to determine the maximum forces required to separate the lid. However, other angles of pull may be acceptable.

Cold Chain

Pharmaceuticals that have a short shelf life may require Thermal or Cold Chain Packaging to maintain a regulated temperature. These pharmaceutical packages must endure precise temperatures ranging from 2 degrees Celsius to 10 degrees Celsius.

ASTM F2825 is used for the climatic stressing of overnight or two-day delivery systems of a single parcel. The ASTM F2825 testing procedure does not cover refrigerated, frozen food storage, or cryogenic storage conditions.

NSF/ANSI 456 defines criteria for units used to store vaccines. This type of testing consists of refrigerators, freezers, and combination units. Maintaining critical refrigeration and freezer temperatures for vaccines, such as SARS-CoV-2, has created a unique class of storage devices compared to traditional residential and commercial refrigeration units.

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Expert Laboratory Pharmaceutical Package Testing

At Keystone, we test to make sure specific package regulations are met. We also ensure that the pharmaceuticals reach their destination safely and are ready to be administered. Below is a list of the most common tests that can be used specifically for pharmaceuticals.

Pharmaceutical companies partner with us for package testing because of our high-quality work. We take pride in being a full-service testing laboratory that delivers accurate testing and reports in a timely fashion.

Contact us or request a quote to see why customers appreciate the transparency and experience that we bring to every test. We look forward to working with you!